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CEN

prEN ISO 15193

(Main)

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)

DOW = DAV + 36 months

In‑vitro-Diagnostika - Anforderungen an Referenzmessverfahren (ISO/DIS 15193:2023)

Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des échantillons d'origine biologique - Exigences relatives au contenu et à la présentation des procédures de mesure de référence (ISO/DIS 15193:2023)

Diagnostični medicinski pripomočki in vitro - Zahteve za referenčne merilne postopke (ISO/DIS 15193:2023)

General Information

Status
Not Published
Publication Date
21-Jul-2025
ICS
11.100.10 - In vitro diagnostic test systems
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 3 - Quality management in the medical laboratory
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
19-Mar-2024
Completion Date
19-Mar-2024
Directive
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
oSIST prEN ISO 15193:2024 - In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023)

Relations

Revises
EN ISO 15193:2009 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
Effective Date
10-Mar-2021

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SLOVENSKI STANDARD
01-marec-2024
Diagnostični medicinski pripomočki in vitro - Zahteve za predstavitev referenčnih
merilnih postopkov (ISO/DIS 15193:2023)
In vitro diagnostic medical devices - Requirements for reference measurement
procedures (ISO/DIS 15193:2023)
In‑vitro-Diagnostika - Anforderungen an Referenzmessverfahren (ISO/DIS 15193:2023)
Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des
échantillons d'origine biologique - Exigences relatives au contenu et à la présentation
des procédures de mesure de référence (ISO/DIS 15193:2023)
Ta slovenski standard je istoveten z: prEN ISO 15193
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 15193
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-12-26 2024-03-19
In vitro diagnostic medical devices — Requirements for
reference measurement procedures
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15193:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15193:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15193
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:

In vitro diagnostic medical devices — Requirements for
reference measurement procedures
ICS: 11.100.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15193:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 15193:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements for a reference measurement procedure .10
4.1 General . 10
4.2 Elements of a reference measurement procedure . 10
4.3 Warning and safety precautions . 11
4.4 Introduction . 11
4.5 Scope . .12
4.6 Terms, definitions, symbols, and abbreviated terms .12
4.6.1 Concepts .12
4.6.2 Nomenclature . 12
4.6.3 Trivial names .12
4.7 Measurement principle and measurement method .12
4.8 Reagents and materials .13
4.8.1 General .13
4.8.2 Descriptive items .13
4.8.3 Influence quantities . 14
4.8.4 Expression of concentration . 14
4.8.5 Expression of dilution . 14
4.8.6 Reference to patented items . 15
4.9 Apparatus and equipment .15
4.9.1 Description .15
4.9.2 Auxiliary equipment .15
4.10 Consumables . . . 15
4.11 Sampling and sample .15
4.11.1 General .15
4.11.2 Samples .15
4.12 Preparation of measuring system and analytical portion . 16
4.12.1 General . 16
4.12.2 Preparation of apparatus . 16
4.12.3 Calibration . . . 16
4.12.4 Types of analytical sample . 16
4.12.5 Design of analytical series . 17
4.12.6 Analytical portion . 17
4.12.7 Analytical solution . 17
4.13 Operation of measuring system . 17
4.13.1 Sequence of measurement steps . 17
4.13.2 Blank . 17
4.13.3 Validation of measurement conditions . 17
4.14 Data processing. 18
4.14.1 Calculation of measurement results . 18
4.14.2 Conversion equations . 18
4.15 Validation . 18
4.15.1 Concepts, values, and their use . . 18
4.15.2 Analytical calibration function . 19
4.15.3 Analytical measurement function . 19
4.15.4 Analytical sensitivity . 19
4.15.5 Analytical influence quantities . 19
4.15.6 Blank measurement . 19
4.15.7 Recovery studies . 19
iii
ISO/DIS 15193:2023(E)
4.15.8 Measurement trueness .20
4.15.9 Measurement precision .20
4.15.10 Repeatability standard deviation, s . 20
r
4.15.11 Intermediate precision standard deviation . 20
4.15.12 Reproducibility standard deviation, s . 20
R
4.15.13 Limit of detection . 20
4.15.14 Measuremen
...

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